Epstein-Barr Virus infection MedDRA version: 20.0 Level: LLT Classification code 10014077 Term: EBV infection System Organ Class: 100000004862 MedDRA version: 23.0 Level: LLT Classification code 10014078 Term: EBV infection reactivation System Organ Class: 100000004862 MedDRA version: 21.1 Level: LLT Classification code 10056906 Term: EBV antibody positive System Organ Class: 100000004848 MedDRA version: 21.0 Level: LLT Classification code 10056907 Term: EBV antigen positive System Organ Cla
Conditions
Interventions
Trade Name: 2LEBV®
Product Name: 2LEBV®
Product Code: NA
Pharmaceutical Form: Pillules
Pharmaceutical form of the placebo: Pillules
Route of administration of the placebo: Oromucosal use
Trade Name:
Sponsors
LABO'LIFE Belgium sprl
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients, male or female, aged 12 years and older, - Patient with significant fatigue for 1 month or more, - Patient with at least two other symptoms among the following: Long-lasting exhaustion even after light exertion, subfebrile state, fever, loss of appetite, nausea, angina, conjunctivis, sensitive cervical or axillary lymph nodes, erythematous and swollen tonsils, headaches, sore throat, myalgia, muscular weakness, arthralgia, splenomegaly, visual disorders, memory disorders, attention deficit disorders, sleep disorders, gastrointestinal disorders, breathing disorders, cardiovascular disorders. - Patient (and/or parents if necessary) agrees to perform serology for the study, - Patient (and parents if necessary) agrees to perform lymphocyte typing for the study, - Patients (and parents if necessary) having the faculties to understand and respect the constraints of the study, - Signature of the Informed Consent Form by the patient (and parents if necessary). - Patient who have a positive serology for EBV (IgG and/or IgM positive). Are the trial subjects under 18? yes Number of subjects for this age range: 44 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: - Patient who have received any treatment with the 2LEBV® or 2LXFS®, - Patients who have received any homeopathic treatment in the previous 2 months prior to the study, - Patients under immunosuppressive treatment, - Patient undergoing treatment for psychiatric disorders, - Patients having received immunotherapy or micro-immunotherapy during the last 3 months, - Patients with known lactose intolerance, - Pregnant or breastfeeding women, - Patients who participated in a clinical study in the previous 2-months period, - Patients (and/or parents of patients if necessary) who are not sufficiently motivated to engage on the total study follow-up period, or likely to travel or to move before the end of the study, - Patients with severe immunodeficiency disease requiring long term treatment (*) or patients under chemotherapy or radiotherapy, - Patients under homeopathic or phytotherapy treatment, - Patients addicted to or using recreational drugs, - Patient under guardianship and/or curatorship, (*) important renal or respiratory insufficiency, transplanted or grafted patients, HIV/AIDS, terminal cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of the efficacy of the treatment on fatigue severity at the end of the treatment between the 2LEBV® or the 2LXFS®/2LEBV® group versus the placebo group.;Secondary Objective: - Comparison of the efficacy of the treatment on other dimensions of the CIS questionnaire (other than fatigue) at the end of the treatment (V4) between the 2LEBV® or the 2LXFS®/2LEBV® group versus the placebo group - Comparison of the efficacy of the treatment on fatigue severity and other dimensions of the CIS questionnaire at 3 months (V3) and 12 months (V5) between the 2LEBV® or the 2LXFS®/2LEBV® group versus the placebo group. - Comparison of the efficacy of the treatment on other symptoms related to EBV infection and their duration between the 2LEBV® and 2LXFS®/2LEBV® group versus the placebo group at V3, V4 and V5. - Comparison of the evolution of the lymphocytes typing between the 2LEBV® and 2LXFS®/2LEBV® group versus the placebo group at each visit until V5. - Comparison of the evolution on IgG between the 2LEBV® and 2LXFS®/2LEBV® group versus the placebo group between V0, V1 and V4 - Safety issues. ;Primary end point(s): The general fatigue scale of the MFI-20 questionnaire at the end of the treatment.;Timepoint(s) of evaluation of this end point: 6-month visit - V4. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Physical fatigue, reduced activity, reduced motivation and mental fatigue scales on the MFI-20 questionnaire at V4, - 5 scales on the MFI-20 questionnaire at V3 and V5, - Other EBV related infection symptoms: Long-lasting exhaustion even after light exertion, subfebrile state, fever, loss of appetite, nausea, angina, conjunctivis, sensitive cervical or axillary lymph nodes, erythematous and swollen tonsil, headaches, sore throat, myalgia, muscular weakness, arthralgia, splenomegaly, visual disorders, memory disorders, attention deficit disorders, sleep disorders, gastrointestinal disorders, breathing disorders, cardiovascular disorders at V3, V4 and V5 and duration of these symptoms (only for symptom that can be assesses by patients) - Lymphocytes typing and immune status (normo, hypo or hyperactive immune system) at V1, V3, V4 and V5, - IgG anti-EA, anti-VCA and anti-EBNA at V0, V1 and V4 - Safety: occurrence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug. ;Timepoint(s) of evaluation of this end point: - 6 months - V4, - 3 months - V3 and 12 months - V5, - 3 months - V3, 6 months - V4 and 12 months - V5 - Inclusion visit - V1, 3 months - V3, 6 months - V4 and 12 months -V5, - pre-inclusion visit - V0, Inclusion visit - V1 and 6 months - V4 - Until 6 months | — |
Countries
Belgium
Contacts
Public ContactClin research Coord, Léa FERRAND
LABO'LIFE France
Outcome results
None listed